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This article applies to selling in: Japan

Medical devices and accessories

Examples of permitted listings

Note: All listings and products must comply with all laws and regulations.

Following products that have the Pharmaceutical and Medical Device Law(*) and other laws and regulations, administrative interpretations and guidelines (“Laws”)-required labeling and are not otherwise restricted from selling or advertising under the Laws and all the Amazon policies.

  • General medical devices
  • Controlled medical devices (Including specially controlled medical devices.)
  • Highly controlled medical devices

(*) Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (PMD Act) of Japan (Act No. 145 of 1960, as amended)

In addition to approval for products, sellers who intend to sell highly controlled medical devices or specific maintenance management medical devices need to get permission from the prefectural governor of the location, and sellers who intend to sell controlled medical devices (excluding specific maintenance management medical devices) need to notify the prefectural governor of the location. For more information, please see the following link.

Tokyo Metro Bureau of Social Welfare and Public Health: "About medical device sales business and lending business"

http://www.fukushihoken.metro.tokyo.jp/kenkou/iyaku/sonota/sale_leas/ (Japanese)

In Amazon, there is a prescribed procedure to sell medical devices. For more information, please see the following link:

Guidelines for Selling Medical Devices (for Marketplace Merchants)

https://sellercentral.amazon.co.jp/gp/help/external/202112340

Examples of prohibited listings

  • Unapproved Medical Devices
    • Products to be used for medical or equivalent practices on the human body, but that are not approved as medical devices (i.e. Unapproved Medical Devices) in Japan (for example, mole removal cream or unapproved laser epilators)
    • Other medical devices which are not allowed to advertise or sell in Japan

      MHLW (Ministry of Health, Labour and Welfare):Information of health damage and unapproved drugs

    http://www.mhlw.go.jp/kinkyu/diet/musyounin.html (Japanese)

  • Products that require a prescription or a medical professional's supervision or direction for their purchase and use by laws or notifications from regulatory agencies. For listing contact lenses, please refer to the Listing Guideline of Drugstore.
  • Repackaging products

    Taking off-the-shelf products from their containers or encapsulations and splitting them into multiple packages for sale is prohibited.

  • Unauthorized imported products

    AShipping imported products to a buyer or adopting a similar method for listing products (a seller who doesn’t have a marketing license for medical devices in Japan receives orders and another seller outside of Japan ships products to a buyer) is prohibited. For more information, please see the following link (Japanese):

    http://www.mhlw.go.jp/kinkyu/diet/tuuchi/0828-4.html

  • Prohibited imports by customs (Japanese):

    http://www.customs.go.jp/mizugiwa/kinshi.htm

  • Products intended to defeat a drug test, such as urine additives and synthetic urine.
  • Products that are adulterated, misbranded or mislabeled.
  • Products that have been the subject of a prior US regulatory action, such as:
    • Food and Drug Administration (FDA) warning letters, safety alerts, or recalls
    • Drug Enforcement Administration (DEA) emergency scheduling
    • Federal Trade Commission (FTC) orders or guidance
  • Products that are unapproved for advertisement, use or sale by the MHLW or any or the other regulatory agencies.
  • Products and products that contain ingredients that the MHLW or any other regulatory agencies have determined present an unreasonable description of injury or illness, or are otherwise unsafe.
  • Listings claiming that a product is intended to be used for the diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals unless the claim is approved by laws, or the MHLW or any other regulatory agencies.
  • Products that contain controlled substances that are not allowed to be advertised or sold pursuant to laws or regulations.
  • Products that have passed their expiration dates (used-by date or period of durability).
  • Opened or used products.
  • Products that are not sealed in original manufacturer's packaging.
  • "Tester", "Not for retail sale", or "Not intended for resale" products and products labeled as "tester", "Not for retail sale", or "Not intended for resale".
  • Products that do not have a required labeling.
  • Products that have been the subject of recalls or safety alerts or warnings.
  • Products that have been the subject of criminal enforcement, injunctions, or seizures.
  • Products or ingredients that are subject to the MHLW or any or the other regulatory agencies warning letter.
  • Medical Devices, Accessories and other products which Amazon does not allow to sell, such as:
    • Specially controlled medical devices, specific maintenance management medical devices (e.g. pulse oximeters) and highly controlled medical devices that are sold in FBA (Fulfillment by Amazon).
  • Professional medical devices that are advertised or sold to general customers without showing that are professional medical devices.
  • Products that have been altered to change the product's performance, safety specifications, or indications of use.
  • Products for which a premarket notification is required but has not yet been filed.
  • Laser productsProducts that Amazon does not allow to sell.
  • Other products that Amazon does not allow to sell.

Additional useful information

Pharmaceuticals and Medical Devices Agency: Medical Devices

https://www.pmda.go.jp/safety/info-services/devices/0091.html (Japanese)

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